In short

Sinus health company SinuSys Corporation has seen study results featuring its Vent-Os™ Sinus Dilation System presented as a poster presentation at the 2013 Combined Otolaryngology Spring Meetings (COSM) being held this week in Orlando, FL. The clever Vent-Os System is designed to gently open the sinus ostia by expanding as it absorbs bodily fluids.

The device met its primary safety and effectiveness endpoints in its initial three month clinical study.

Background

We last covered news from SinuSys Corporation last September when its sinus dilation system, then named AerOs, gained CE mark approval. Find that piece here.

Unlike balloon dilation devices that use rapid, high-pressure inflation, the Vent-Os (formerly AerOs) Sinus Dilation System is a low pressure, self-expanding insert designed to gently and gradually open the maxillary ostia. The Vent-Os System incorporates the Company’s proprietary osmotic technology, which utilizes the body’s natural fluids to expand the insert. After the ostia are opened, the insert is removed. The low-pressure, gradual expansion and simplicity of the device are designed to make it compatible for use in office-based procedures under local anesthesia.

Chronic sinusitis affects more than 31 million people in the United States. It is more prevalent than heart disease and asthma, and has a greater impact on patients’ quality of life than chronic back pain or congestive heart failure.

The U.S. healthcare system currently spends more than $8 billion annually on improving the health of patients with sinus conditions. However, approximately 20 percent of sinusitis patients do not experience adequate relief from current pharmaceutical treatments, which can have unpleasant side effects even when effective. For these patients, the most effective treatments to-date have been Functional Endoscopic Sinus Surgery (FESS) and high-pressure balloon dilation, which can cause significant patient discomfort and are conducted in a surgical suite under general anesthesia or IV sedation.

The study

Twelve chronic rhinosinusitis (CRS) patients with maxillary sinus disease requiring FESS were enrolled in the study, which was conducted at the University of British Columbia in Vancouver, Canada. The Vent-Os device was inserted into the maxillary sinus opening (MSO) at the start of surgery and removed after 60 minutes. No adverse events occurred during insertion or removal of the device. Ten patients completed three-month follow-up. In these patients, fourteen MSOs were evaluated for patency, of which thirteen (93 percent) were confirmed patent via endoscopy. The remaining opening was confirmed patent via subsequent CT scan, thereby confirming restoration of natural sinus drainage and ventilation.

Additional results from the study will be presented by Dr. Javer at the 2nd Meeting of European Academy of ORL and Head and Neck Surgery to be held on April 27-30 in Nice, France.

Physician comments

“Our initial clinical study of the Vent-Os System in FESS patients demonstrated the ability of the device to establish and maintain patency of the maxillary sinus ostia, as well as its potential as an option to treat earlier-stage CRS patients under local anesthesia,” said Amin Javer, MD FRCSC FARS, Director of the St. Paul’s Sinus Centre and Assistant Clinical Professor at the University of British Columbia.

Company comments

“We are enthusiastic about the positive clinical results for the Vent-Os System, and are encouraged about the opportunity to provide a simple, highly tolerable treatment option for early-stage sinusitis patients in an office setting,” said SinuSys Chief Executive Officer Thomas Schreck.

Regulatory status

The Vent-Os System has received the CE Mark, Health Canada license and Australian Therapeutic Goods Administration (TGA) Certificate, and is currently being commercialized in those regions. Availability in the US is pending a 510(k) currently under review by FDA.